(253 days)
The BioDynamik XT3 System is indicated for fracture fixation and bone transport of the tibia in adults.
The XT3 System is composed of the XT3 fixator, Half Pins, and instrumentation, which includes a Spacer, a Drill and Cut Guide, and drivers. The XT3 Fixator and instruments are single-use devices and are supplied non-sterile intended to be steam sterilized prior to use. The Half Pins are provided sterile by gamma irradiation and are for single use only. The XT3 fixator can be adjusted via an incorporated lifting plate to provide fracture fixation or bone transport.
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Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table detailing acceptance criteria for a quantitative performance metric and the XT3 System's corresponding performance. Instead, it describes general compliance with standards and successful completion of tests.
| Acceptance Criteria (General) | Reported Device Performance (XT3 System) |
|---|---|
| Compliance with ASTM F1541-17 Annex 7 | Comprehensive testing performed per ASTM F1541-17 Annex 7 for axial load and four-point bend tests. |
| Meeting design inputs | Mechanical testing results verified to meet design inputs. |
| Substantial equivalence to predicate device | Objective comparison of performance testing results demonstrate substantial equivalence to the predicate device. |
| Passing acceptance criterion for static loads | All XT3 samples passed respective acceptance criterion for static axial compression, A-P and M-L four-point bending, and torsion. |
| Successful use for intended purpose | Cadaver testing performed to demonstrate the XT3 System could be used successfully in accordance with the intended use. |
| Substantial equivalence in technological features and principles of operation | Key technological features and principles of operation are substantially equivalent to the primary predicate Orthofix Modulsystem. |
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Sample size used for the test set and the data provenance:
- Test set sample size: While "All XT3 samples" are mentioned as passing their respective acceptance criteria for static loads, a specific numerical sample size for independent test sets for each test (axial, four-point bend, torsion, cadaver) is not provided in the document.
- Data provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for the test set. The tests described are mechanical performance tests (compliance with ASTM standards, cadaver testing for successful use), which typically rely on objective measurements rather than expert interpretations or ground truth.
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Adjudication method for the test set:
- Not applicable. The described tests are primarily mechanical and cadaveric performance tests, not studies requiring adjudication of output from multiple readers or algorithms.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The provided text describes a medical device (XT3 System - an external fixation device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The XT3 System is a physical medical device for fracture fixation and bone transport, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical tests (axial load, four-point bend, torsion), the "ground truth" or reference for performance is established by the acceptance criteria defined within ASTM F1541-17 Annex 7 and the device's own design inputs.
- For cadaver testing, the "ground truth" is the successful demonstration that the XT3 System could be used in accordance with its intended use in a simulated anatomical environment.
- No expert consensus, pathology, or outcomes data are mentioned as ground truth in the context of the described performance studies.
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The sample size for the training set:
- Not applicable. The XT3 System is a physical medical device, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.